FDA Drug recall D-0334-2021
Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC,…
- FDA Drug
- Class II
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC,… by Sun Pharmaceutical Industries, citing microbial Contamination of Non-Sterile Product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0334-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-31 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02.
Reason
Microbial Contamination of Non-Sterile Product
Identifiers
| ndc | 10631-238-01 |
|---|---|
| ndc | 10631-238-02 |
| ndc | 10631-206-01 |
| ndc | 10631-206-02 |
| code_info | Lot #: J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0334-2021%22
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